Table 2 Comparison of adverse events overall and by severity
Mixed Motavizumab/Palivizumab (n = 83) | Mixed Palivizumab/Motavizumab (n = 83) | Motavizumab Only (n = 93) | |
|---|---|---|---|
Total number of AEs | 405 | 408 | 459 |
Number (%) of children reporting: | |||
≥1 AE | 77 (92.8) | 75 (90.4) | 83 (89.2) |
≥1 Level 1 AE, as the highest severity | 17 (20.5) | 26 (31.3) | 22 (23.7) |
≥1 Level 2 AE, as the highest severity | 44 (53.0) | 44 (53) | 51 (54.8) |
≥1 Level 3 AE, as the highest severity | 13 (15.7) | 5 (6.0) | 6 (6.5) |
≥1 Level 4 AE, as the highest severity | 3 (3.6) | 0 (0.0) | 4 (4.3) |
≥1 Related AE | 14 (16.9) | 16 (19.3) | 21 (22.6) |
≥1 SAE | 19 (22.9)a | 7 (8.4)a | 11 (11.8) |
≥1 Level 1 SAE, as the highest severity | 1 (1.2) | 0 (0.0) | 0 (0.0) |
≥1 Level 2 SAE, as the highest severity | 4 (4.8) | 4 (4.8) | 4 (4.3) |
≥1 Level 3 SAE, as the highest severity | 11 (13.3)a | 3 (3.6)a | 4 (4.3) |
≥1 Level 4 SAE, as the highest severity | 3 (3.6) | 0 (0.0) | 3 (3.2) |
≥1 Related SAE | 2 (2.4) | 0 (0.0) | 1 (1.1) |
≥1 AE resulting in discontinuation of study drug | 3 (3.6) | 0 (0.0) | 0 (0.0) |
≥1 Related AE resulting in discontinuation of study drug | 2 (2.4) | 0 (0.0) | 0 (0.0) |
Death | 2 (2.4) | 0 (0.0) | 1 (1.1)b |